Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
17.6 mg/m³
Most sensitive endpoint:
carcinogenicity
DNEL related information
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
35.2 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
Overall assessment factor (AF):
1
Modified dose descriptor starting point:
NOAEC

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
17.6 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
Dose descriptor:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
35.2 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
Overall assessment factor (AF):
1
Dose descriptor starting point:
NOAEC

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.42 mg/kg bw/day
Most sensitive endpoint:
carcinogenicity
DNEL related information
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

In accordance with REACH guidance (Appendix R.8-13) and since no new scientific information has been obtained under REACH which would contradict the use of the proposed IOELV, for the purposes of this submission the proposed IOELVs (STEL and 8-h TWA) are used in place of acute and long-term DNELinhalation values for workers.  In accordance with REACH guidance (R.8), DNEL values are proposed since vinyl acetate has a threshold mode of action i.e. NOAEL/NOAECs are identified for all relevant endpoints.  The IOELV has been established based on the NOAEC of 50 ppm for histological changes in respiratory tissues of rodents and, based on limited observations in humans, the reported threshold for irritancy in humans, considered to be 10 ppm.

The adopted STEL is 10 ppm (35.2 mg/m³) and 8 h TWA, 5 ppm (17.6 mg/m³), as concluded by SCOEL in October 2005 (SCOEL/SUM/122) and published in December 2009 (EC, 2009). 

15% absorption (uptake) via inhalation, 50% via oral and 90% dermal absorption (both values are used in concurrence with the RAR).

Reference: EC (2009) Commission Directive 2009/161/EU of establishing a third list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC and amending Commission Directive 2000/39/EC.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Based on the identified uses for vinyl acetate, no DNELs are proposed since relevant exposure of the general population is not expected due to the following reasons:

  1. The sole identified use for vinyl acetate is the use as a monomer in industrial (co-) polymerization processes, and there is no direct consumer use of vinyl acetate monomer.
  2. Vinyl acetate occurs only as residual monomer in homo- and copolymers, the residual vinyl acetate monomer content in homo- and copolymers (range < 2 - 3000 ppm) depends on the polymer and its field of application. The quantitatively weighted median value of the residual monomer content amounts to 3000 ppm (EU RAR 2008).
  3. In addition, the initial residual monomer concentration in the polymers decreases rapidly during subsequent processing steps due to off-gassing at industrial facilities as well as due to hydrolysis of residual monomer.
  4. Consumer uses of vinyl acetate (co)polymers with an initial residual vinyl acetate monomer content of significantly less than 3000 ppm may results in consumer exposure at negligible levels.
  5. The EU RAR (2008) concludes for consumers that “There is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied already.” (Conclusion ii)